The Effectiveness of Prophylactic Antibiotics for Urethral Bulking

Part of paid clinical trials in Morristown, New Jersey.

Sponsor
Atlantic Health System
Study ID
NCT06261736
Status
Recruiting
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Conditions

  • Postoperative Urinary Tract Infection
  • Stress Urinary Incontinence
  • Urethral Bulking

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prophylactic antibiotics — OTHER
    These participants will be given a single dose of an oral antibiotic prior to the procedure.
  • No antibiotics — OTHER
    These participants will not be given an antibiotic prior to the procedure.

Study Details

The goal of this clinical trial is to evaluate if prophylactic antibiotics in urethral bulking are effective in reducing postprocedural urinary tract infections.

Key Dates

Start date
Oct 24, 2023
Status verified
Apr 2025
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Antibiotic Group
    Those randomized to this group will receive a one-time dose of an oral antibiotic prior to the urethral bulking procedure. The antibiotic will be based on the participants' allergies, medical history, and current medication list.
  • Other: No antibiotic group
    Those randomized to this group will not receive an antibiotic prior to the urethral bulking procedure.

Primary Outcome Measure

Rate of urinary tract infection (UTI) [ Time Frame: Within 4 weeks after the procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atlantic HealthMorristownNew Jersey07960
Tess Gao, MD
[email protected]
9739717267
Erika Wasenda, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Atlantic Health· Morristown, NJ

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